FDA records indicate that there are no current recalls for this drug.
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Non-aspirin Sinus Congestion And Pain Recall
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Questions & Answers
Side Effects & Adverse Reactions
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
- If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 8 caplets in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
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- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- you have liver disease
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis. or kidney disease
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- you are taking a diuretic
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- you have asthma
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- a prescription drug for diabetes, gout, or arthritis
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- any other drug, or are under a doctor’s care for any serious condition
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- an allergic reaction occurs. Seek medical help right away.
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you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- ringing in the ears or loss of hearing occurs
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- painful area is red or swollen
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- pain gets worse or lasts for more than 10 days
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- fever gets worse or lasts for more than 3 days
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- any new symptoms appear
- These could be signs of a serious condition
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- •
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- you have liver disease
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
- •
- you have high blood pressure, heart disease, liver cirrhosis. or kidney disease
- •
- you are taking a diuretic
- •
- you have asthma
- •
- a prescription drug for diabetes, gout, or arthritis
- •
- any other drug, or are under a doctor’s care for any serious condition
- •
- an allergic reaction occurs. Seek medical help right away.
- •
-
you experience any of the following signs of stomach bleeding:
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- feel faint
- •
- vomit blood
- •
- have bloody or black stools
- •
- have stomach pain that does not get better
- •
- ringing in the ears or loss of hearing occurs
- •
- painful area is red or swollen
- •
- pain gets worse or lasts for more than 10 days
- •
- fever gets worse or lasts for more than 3 days
- •
- any new symptoms appear
- These could be signs of a serious condition
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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temporarily relieves minor aches and pains due to:
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- headache
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- a cold
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- arthritis
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- muscular aches
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- toothache
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- premenstrual & menstrual cramps
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Non-aspirin Sinus Congestion And Pain Manufacturers
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Fred’s, Inc.
Non-aspirin Sinus Congestion And Pain | Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
drink plenty of clear fluids to help prevent dehydration caused by diarrhea take only on an empty stomach (1 hour before or 2 hours after a meal) find right dose on chart below. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years
(60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years
(48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years
(up to 47 lbs) ask a doctor
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